BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States

AstraZeneca

Status and phase: Withdrawn; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Saxagliptin/Metformin XR FDC; Drug: Saxagliptin; Drug: Metformin XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01305551

CV181-146

Details and patient eligibility

About

The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin extended release (XR) fixed dose combination (FDC) tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) tablets administered together in both the fasted and fed states.

Full description

Primary purpose: To demonstrate the bioequivalence of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin XR FDC tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) tablets administered together in both the fasted and fed states.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women
• Women of childbearing potential (WOCBP) who are using acceptable method of contraception
• Women who are not nursing

Exclusion criteria

• History of Gastrointestinal (GI) disease
• Any GI surgery that could impact study drug absorption
• History of allergy to drug class or related compounds
• History of allergy to metformin or other similar acting agents.
• History of any significant drug allergy.
• Estimated creatinine clearance (ClCr) < 80 mL/min using Cockcroft-Gault formula

Trial design

0 participants in 4 patient groups

Treatment A-Saxagliptin+Metformin XR

Experimental group

Description:

5mg Saxagliptin + 500 mg Metformin XR Tablets, once on Day 1 only, administered together in the fasted state.

Treatment:

Drug: Metformin XR

Drug: Saxagliptin

Treatment B-Saxagliptin/Metformin XR FDC

Experimental group

Description:

5mg Saxagliptin / 500 mg Metformin XR FDC tablet, once on Day 1 only, administered in the fasted state.

Treatment:

Drug: Saxagliptin/Metformin XR FDC

Treatment C-Saxagliptin+Metformin XR

Experimental group

Description:

5mg Saxagliptin + 500 mg Metformin XR Tablets, once on Day 1 only, administered together in the fed state.

Treatment:

Drug: Metformin XR

Drug: Saxagliptin

Treatment D-Saxagliptin/Metformin XR FDC

Experimental group

Description:

5mg Saxagliptin / 500 mg Metformin XR FDC tablet, once on Day 1 only, administered in the fed state.

Treatment:

Drug: Saxagliptin/Metformin XR FDC